drugset / Trial / NCT02476552

Absorption, Metabolism, Excretion, and the Determination of Absolute Bioavailability of Niraparib in Subjects With Cancer

NCT02476552

Phase 1 Completed 12 enrolled Tesaro, Inc.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is an open-label study with 2 parts, plus an extension study following completion of Parts 1 or 2, that is being conducted in approximately 12 subjects (6 subjects in Part 1; 6 subjects in Part 2) with cancer to examine the absorption, metabolism, excretion, and absolute bioavailability of niraparib.

Timeline

Start
2015-02
Primary completion
2015-12
Completion
2018-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Niraparib Small molecule 100 ug Oral
Subject Niraparib Small molecule 300 mg Oral

Indications